Acme Monaco Corporation

Address:1450 Central Drive,PRESQUE ISLE,ME,04769,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Wire, Orthodontic (DZC) (10)

Premarket Exempt

Yes

Clear

Archwire - D972AMC18LMNITI10E2 Catalog Number :

Device Description : 018 LWR NAT MEDIUM (TRUFORM) NITI 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Archwire - D972AMC18LNITI6A1 Catalog Number :

Device Description : 018 LWR NAT NITI

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC18LNMCUN3510E2 Catalog Number :

Device Description : 018 LWR NAT MEDIUM (TRUFORM) COPPER NITI 35° C 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Archwire - D972AMC18RCLL10E2 Catalog Number :

Device Description : 018 LWR R/C NITI 10/ENV

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Archwire - D972AMC18RCUL10E2 Catalog Number :

Device Description : 018 UPR R/C NITI 10/ENV

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Archwire - D972AMC18RNITI25EZU1 Catalog Number :

Device Description : 018 UNIV NITI - 25/ENV

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ArchWire - D972AMC18RST25E4 Catalog Number :

Device Description : 018 UNIV S/S ST 25/ENV

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 25

Straight Wire - D972AMC18SC14ST25T6Q1 Catalog Number :

Device Description : 018 S&C 14" S/S ST 25/TUBE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC18UMNAT25EYZ1 Catalog Number :

Device Description : 018 UPR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC18UMNITI10E2 Catalog Number :

Device Description : 018 UPR NAT MEDIUM (TRUFORM) NITI 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

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